Unanticipated Problem Report Forms Should Be Submitted to the Office of Research, Or Via

/ Institutional Review Board
UNANTICIPATED PROBLEM REPORT FORM

Unanticipated problem report forms should be submitted to the Office of Research, or via email to . Electronic submissions are encouraged.

General Information

Project Title:

Principal investigator:

Mailing address:

P. I’s Telephone number:

Email:

Did the problem occur at a local site or an outside site ?

Date of the unanticipated problem:

Date the research team discovered the problem:

Date and description of latest study-related intervention (relevant to this event):

Did the problem result in injury to the participant? Yes No

If yes, please describe:

Description of Unanticipated Problem
(adverse event, incident, experience, or outcome)

List key words describing the problem (e.g., a breach of confidentiality):

Briefly describe the problem (Include information such as nature of the unanticipated problem, description of the situation that led to the problem, individuals present, referral for medical/psychological care, etc.):

Determination of Unanticipated Problem

Yes NoThe problem is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied.

If yes, explain the basis for determining that the problem is unexpected:

Yes NoThe problem is related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).

If yes, explain the basis for determining that the problem is related or possibly related:

Yes NoThe problem places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

If yes, explain the basis for determining that the problem placed participants or others at a greater risk of harm:

If you checked NO to any of the items in Section III above, the problem is not consideredan “unanticipated problem” and you are not required to complete and submit this form tothe IRB. However, you are required to report the problem in the summary to the IRB at thetime of continuing review (annual review).

Corrective Actions

Yes NoShould the protocol be revised?

If yes, provide a description of the proposed protocol changes and attach a revised protocol (with changes indicated):

Yes NoShould the research be suspended or terminated?

If yes, describe procedures you will follow for the suspension or termination of the research:

Yes NoShould enrolled participants be notified about this problem/event?

If yes, attach a revised consent form or draft letter of notification with this report.

Yes NoShould other corrective action be taken in response to the unanticipated problem?

If yes, provide a description of the proposed corrective action:

Notification of Entities

Yes No N/ASponsor has been notified (either federal or non-federal).

FOR IRB USE ONLY

UW IRB chair/designee review of problem report:

The problem:

Does not represent an unanticipated problem involving risks to participants or others (review by expedited procedures)

Does represent an unanticipated problem involving risks to participants or others (refer to convened IRB for review)

______

Signature of IRB chair/designeeDate

Investigator’s signatureDate

DRAFT 8.23.17